Shares of Paris-based biotechnology firm Abivax climbed 36% on Tuesday following the release of updated clinical trial results for its lead drug candidate, obefazimod, an experimental oral treatment for moderate to severe ulcerative colitis.
The latest data from the maintenance phase of the Phase 3 ABTECT trial demonstrated what the company described as “clinically meaningful improvements” in adult patients, including those whose disease had previously failed to respond to other therapies. After 44 weeks, 37.2% of patients who had not responded during the initial treatment phase achieved clinical remission, meaning their symptoms had largely subsided. Additionally, 34.5% showed healing of the bowel lining, a key marker of disease control.
For patients whose condition relapsed after an initial improvement, increasing the obefazimod dose to 50 mg helped 45.5% regain remission, according to the company’s statement.
Safety Data Reassures Investors
The positive update comes just weeks after Abivax shares plunged 44% on 2 June, following the release of earlier Phase 3 safety data from the same trial. The company has now provided an expanded safety analysis, which found that cancer rates among treated patients remained within the range typically observed in people with ulcerative colitis.
Combined safety data from the Phase 2 and Phase 3 programmes, representing the equivalent of 1,704 patient-years of treatment, showed that the rate of cancers excluding non-melanoma skin cancer was 0.35 cases per 100 patient-years in the combined treatment group and 0.64 in the 50 mg group. For non-melanoma skin cancer, the rates were 0.59 and 0.64 per 100 patient-years, respectively. The company stated that the analysis did not identify any new or unexpected safety signals.
“The expanded cumulative safety data further strengthens our confidence in the long-term safety profile of obefazimod and reinforces the favourable benefit-risk profile for our programme as we prepare for our planned NDA submission later this year,” said Chief Executive Marc de Garidel in a statement.
Abivax remains on track to submit a New Drug Application (NDA) to the US Food and Drug Administration in the fourth quarter of 2026. The company is also evaluating obefazimod as a treatment for Crohn’s disease, another form of inflammatory bowel disease, which could broaden its commercial opportunity beyond ulcerative colitis. Results from a mid-stage Phase 2 trial are expected in mid-2027.
The French biotech sector has seen growing attention from global investors, and Abivax’s progress underscores the country’s role in developing innovative therapies for chronic inflammatory conditions. For context on how French institutions are navigating broader challenges, see our coverage of Lagarde’s potential early ECB exit and its implications for French political dynamics.
As Europe continues to grapple with rising healthcare demands, the success of homegrown biotech firms like Abivax could have significant implications for patient access to advanced treatments across the continent.
